Description

Levofloxacin, Hemihydrate, USP

Levofloxacin, Hemihydrate, USP is a high-purity, broad-spectrum fluoroquinolone antibiotic used in oral and parenteral formulations for the treatment of bacterial infections affecting the respiratory tract, urinary tract, skin, and soft tissues. As the S-enantiomer of ofloxacin, levofloxacin offers enhanced potency, superior pharmacokinetics, and reduced toxicity compared to its racemic counterpart. Levofloxacin

• Is a USP-compliant fluoroquinolone antibiotic with broad-spectrum antibacterial activity
• Is effective against gram-positive, gram-negative, and atypical pathogens
• Is used in oral tablets, injectable solutions, and ophthalmic formulations
• Is suitable for monotherapy or combination therapy in resistant infections
• Is manufactured under Good Manufacturing Practice (GMP) conditions
• Is supplied with complete regulatory documentation including Certificate of Analysis (CoA), DMF, and supporting technical data

Chemically known as (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate, Levofloxacin Hemihydrate is a white to yellowish crystalline powder that is freely soluble in water. It exhibits bactericidal activity through inhibition of DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and transcription.

In pharmaceutical applications, Levofloxacin, Hemihydrate, USP is used in:

• Oral and IV formulations for respiratory tract infections, including pneumonia, bronchitis, and sinusitis
• Urinary tract and kidney infections, including pyelonephritis
• Skin and soft tissue infections, including MRSA-sensitive indications
• Ophthalmic solutions and drops for bacterial conjunctivitis and corneal ulcers
• Post-surgical prophylaxis and resistant pathogen treatment

Levofloxacin has high oral bioavailability and a long plasma half-life, allowing for once-daily dosing in most regimens. It is generally well tolerated but must be used with caution in patients with tendon disorders or those taking concomitant QT-prolonging medications.

CarboMer supplies Levofloxacin Hemihydrate USP with validated controls on enantiomeric purity, water content, related substances, and particle size distribution. Each batch complies with USP monograph requirements and is suitable for regulated drug manufacturing.

The material is packaged in sealed, moisture-resistant, tamper-evident containers. Available in R&D, pilot, and commercial-scale volumes. Minimum order quantities (MOQ), lead times, and documentation—including CoA, SDS, and regulatory DMF access—are provided upon request.

Each batch is tested for identity (IR, HPLC), assay (anhydrous basis), enantiomeric purity, water content (KF), related compounds, residual solvents, heavy metals, and microbial limits. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full traceability documentation accompany every shipment.

As with all CarboMer APIs, Levofloxacin, Hemihydrate, USP is supported by formulation assistance, global regulatory expertise, and secure sourcing to help you develop safe, effective antibacterial therapies for critical and community-based infections.